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NCT03996252 · ClinicalTrials.gov registry record · Early Phase 1
Combination Topical Therapy for Treatment of Scalp Actinic Keratoses
A Early Phase 1 study, sponsored by Tulane University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
NCT03996252 is a Early Phase 1 study that was terminated before completion, run by Tulane University. The registered enrollment target is 15 participants.
The verdict
NCT03996252, a Early Phase 1 study, was terminated before completion, sponsored by Tulane University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The aim of this study is to determine the effectiveness of combination calcipotriene 0.005% foam and 5% fluorouracil cream for the treatment of actinic keratoses on the scalp. The data obtained will be compared with the current standard of care, monotherapy with 5% fluorouracil cream. A recent randomized, double-blind clinical trial (NCT02019355) compared 0.005% calcipotriol ointment and fluorouracil 5% cream with Vaseline plus fluorouracil 5% cream for a 4-day treatment of actinic keratoses on the face, scalp and upper extremities. They found that calcipotriol plus 5-FU versus Vaseline plus fluorouracil 5% cream led to an 87.8% versus 26.3% mean reduction in the mean number of actinic keratoses. Our study will independently assess the effectiveness of combination treatment (calcipotriene 0.005% foam and fluorouracil 5% cream) on scalp actinic keratoses in a case series of up to 15 eligible participants. Participants will complete a 4-night application of combination treatment with follow-up immediately after and 8 weeks later.
Interventions
- DRUG Calcipotriene 0.005% Foam
- DRUG Efudex 5% Topical Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2020-06-08 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03996252
The ClinicalTrials.gov registry entry for NCT03996252 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tulane University, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Calcipotriene 0.005% Foam is the first listed.
NCT03996252 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03996252 about?
NCT03996252 is a clinical study titled "Combination Topical Therapy for Treatment of Scalp Actinic Keratoses". The aim of this study is to determine the effectiveness of combination calcipotriene 0.005% foam and 5% fluorouracil cream for the treatment of actinic keratoses on the scalp. The data obtained will be compared with the current standard of care, monotherapy with 5% fluorouracil cream. A recent rando...
What is the current status of trial NCT03996252?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2019-07-01. Estimated completion is 2020-06-08.
What interventions are being tested in trial NCT03996252?
The interventions under investigation include: Calcipotriene 0.005% Foam (DRUG), Efudex 5% Topical Cream (DRUG).
Who is sponsoring clinical trial NCT03996252?
This trial is sponsored by Tulane University, which has 73 total clinical trials registered on ClinicalTrials.gov.
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